human papillomavirus (HPV) vaccine, quadrivalent

What is the most important information I should know about human papillomavirus vaccine?

You should not receive a booster vaccine if you have had a life-threatening allergic reaction after the first shot.

You may feel faint during the first 15 minutes after receiving this vaccine. Some people have had seizure-like reactions after receiving this vaccine.

What is human papillomavirus vaccine?

Human papillomavirus (HPV) can cause genital warts, cancer of the cervix, anal cancer, and various cancers of the vulva or vagina.

Gardasil (HPV quadrivalent vaccine) and Gardasil 9 (HPV 9-valent vaccine) are used in both females and males. Another form of HPV vaccine (Cervarix) is used only in females. This medication guide provides information only for Gardasil (HPV quadrivalent vaccine).

HPV quadrivalent vaccine is used in girls and young women ages 9 through 26 to prevent cervical/vaginal/anal cancers caused by certain types of HPV.

HPV quadrivalent vaccine is also used in boys and young men ages 9 through 26 to prevent anal cancer or genital warts caused by certain types of HPV.

You may receive this vaccine even if you have already had genital warts, or had a positive HPV test or abnormal pap smear in the past. However, this vaccine will not treat active genital warts or HPV-related cancers, and it will not cure HPV infection.

HPV quadrivalent vaccine only prevents diseases caused by HPV types 6, 11, 16, and 18. It will not prevent diseases caused by other types of HPV.

The Centers for Disease Control and Prevention (CDC) recommends HPV vaccine for all boys and girls ages 11 or 12 years old. The vaccine is also recommended in teenage boys and girls who have not already received the vaccine or have not completed all booster shots.

Like any vaccine, the HPV quadrivalent vaccine may not provide protection from disease in every person.

HPV quadrivalent vaccine may also be used for other purposes not listed in this medication guide.

What should I discuss with my health care provider before receiving human papillomavirus vaccine?

You should not receive a booster vaccine if you have had a life-threatening allergic reaction after the first shot.

To make sure HPV vaccine is safe for you, tell your doctor if you have:

a fever;

a weak immune system;

an allergy to yeast; or

if you are being treated with cancer medicine, steroids, or other drugs that can weaken your immune system.

This vaccine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether HPV vaccine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

HPV vaccine will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis.

How is human papillomavirus vaccine given?

HPV vaccine is given as an injection (shot) into a muscle in your upper arm or thigh. You will receive this injection in a doctor's office or other clinic setting.

HPV quadrivalent vaccine is given in a series of 3 shots. You may have the first shot at any time as long as you are between the ages of 9 and 26 years old. Then you will need to receive a second dose 2 months after your first shot, and a third dose 6 months after your first shot.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

An HPV vaccine should not be used in place of having a routine pelvic exam, Pap smear, or anal exam to screen for cervical or anal cancer.

What happens if I miss a dose?

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid while receiving human papillomavirus vaccine?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of human papillomavirus vaccine?

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

You may feel faint after receiving this vaccine. Some people have had seizure-like reactions after receiving a human papilloma virus vaccine. Your doctor may want you to remain under observation during the first 15 minutes after the injection.

Developing cancer from HPV is much more dangerous to your health than receiving the vaccine to protect against it. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Call your doctor at once if you have:

severe stomach pain;

fever, chills, swollen glands, general ill feeling;

easy bruising or bleeding, unusual weakness;

joint pain, muscle pain or weakness;

confusion, seizure (convulsions);

chest pain; or

feeling short of breath.

Common side effects may include:

pain, swelling, bruising, redness, or itching where the shot was given;

nausea, vomiting;

headache, dizziness; or

fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

What other drugs will affect human papillomavirus vaccine?

Other drugs may interact with HPV quadrivalent vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about this vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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